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Tests treatment safety and results for Idiopathic Pulmonary Fibrosis (IPF)
Official title A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07344558
What this study is testing
What is MNKD-201(Nintedanib DPI)?
MNKD-201(Nintedanib DPI) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Is ≥40 to ≤85 years of age at the time of signing the informed consent form.
- Diagnosis of IPF
- Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.
- Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening.
- DLCO corrected for hemoglobin [Visit 1] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to...
You likely can't join if
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis...
- Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus...
- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
- Significant Cardiovascular diseases
- Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.
- Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3...
See the full eligibility criteria
- Is ≥40 to ≤85 years of age at the time of signing the informed consent form.
- Diagnosis of IPF
- Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.
- Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening.
- DLCO corrected for hemoglobin [Visit 1] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to Screening, this is to be done during Screening and read locally.
- Has a body weight \>40 kg (\>88 lbs.) at Screening.
- For female participants of childbearing potential, agreement to use acceptable birth control
- For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception
- Is capable of performing spirometry, as required by the study procedures and ATS guidelines.
- CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment.
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia.
- Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis, regardless of whether or not...
- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
- Significant Cardiovascular diseases
- Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.
- Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening.
- Has a history of asthma, with the exception of resolved childhood asthma.
- Has known obstructive lung disease
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 times the upper limit of normal (ULN) during Screening.
- Advanced liver and kidney function.
- Current or recent (within 30 days of Screening) use of nintedanib.
- Use of prednisone \>10 mg/day within 1 month prior to Screening, or other significant immunosuppression
- Active lung cancer (primary or metastatic) or any cancer requiring chemotherapy or radiation therapy within 3 years, except appropriately treated non-melanoma skin cancer, localized non-malignant prostate cancer, or in...
- Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening
- Current alcohol, medication, or illicit drug abuse
- Has lost more than 400 mL blood, e.g., as a blood donor, or donor of blood products, during the 3 months prior to Screening.
- Has received a live vaccine within the 3 months prior to the first dose of study drug.
- Smokes (any substance including electronic cigarettes and marijuana) within 3 months prior to Screening or is an ex-cigarette smoker who gave up \<1 year ago.
- Has oxygen requirement of \> 6 liters/min at rest.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Palm Springs, California, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Winston-Salem, North Carolina, United States
- Charleston, South Carolina, United States
- McKinney, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Palm Springs, California, United States; Doral, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States; Winston-Salem, North Carolina, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.